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Throwing Device Trial

Primary Purpose

Overuse Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Throwing Device
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Overuse Injury focused on measuring Healthy subjects, Athletes, Baseball, Sports research, overuse injuries

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Pilot Phase:

  1. Males or females age 8 to 14 years
  2. Presenting to the Children's Hospital of Philadelphia (CHOP) Physical Therapy Clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements.

Phase 1:

  1. Males or females age 8 to 14 years
  2. Involved in official baseball team and primarily plays as the pitcher

Exclusion Criteria:

Pilot Phase

  1. Injury of any aspect of the throwing arm
  2. Unwillingness to perform all requested motions
  3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures.

Phase 1

  1. Injury or disability impeding ability to perform normal baseball-related movements
  2. Inability/unwillingness to schedule and/or travel to the Human Motion Laboratory
  3. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Throwing Device Phase 1

Arm Description

During Phase 1, subjects that have been recruited, consented, and enrolled will come to the biomechanics laboratory for throwing performance housed at the University of Pennsylvania (Human Motion Laboratory) on the day of their appointment. Subjects will be asked to wear the prototype device during a simulated baseball game (approximately 30-45 pitches), and then will perform a set of other baseball-specific movements while fitted with infrared markers for throwing analysis. This data will be used to develop and refine the algorithm for the prototype.

Outcomes

Primary Outcome Measures

Feasibility of wearing the PhySens throwing device during simulated baseball play
Subjects will be asked to put on the PhySens throwing monitor device prototype at the beginning of their physical therapy session and will wear the device for the duration of the visit or until asked by a member of the study team to remove the device.The device will collect motion data for the duration of the session.

Secondary Outcome Measures

Number of occurrences of injury associated with simulated baseball play
Algorithms will be developed to quantify injury associated with common baseball injures from subjects wearing the prototype device and participate in a simulated game. Participants will pitch approximately 30-45 times using varying pitch types.
Motion Capture Data Quantification common to baseball play
Motion-capture data on movements common to baseball play will be captured from participants wearing the device. Participants will be fitted with 51 infrared reflective markers to enable tracking of limb, torso, and head movement while actions are performed. Movement data will be video recorded and recorded with 12 Motion Analysis Raptor IR cameras

Full Information

First Posted
August 12, 2019
Last Updated
August 10, 2022
Sponsor
Children's Hospital of Philadelphia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04098107
Brief Title
Throwing Device Trial
Official Title
A Low-Cost, Collaborative Tool for the Tracking of Youth Activities to Reduce Risk of Physical Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. Secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.
Detailed Description
With the rise in competitive sports participation in pediatric and adolescent populations, there has also been an increase in overuse injuries. Current methods of overuse injury prevention, such as pitch-counting, fail to account for differing techniques or effort and often ignore the elevated risk for children participating in two or more sports emphasizing the same body part. This wearable device seeks to more accurately monitor overuse to prevent and aid rehabilitation of overuse injuries. Subjects will be asked to fill out a short survey about their athletic activities. They will wear a prototype of a minimal risk throwing device during simulated baseball play in a sports medicine session or at the Human Motion Laboratory. Various motion data from the device and from the Motion Lab analysis will be collected to create and refine an algorithm to quantify workload and throwing movements. The primary endpoint of this study is to quantify motion capture data on movements common to baseball play. The secondary endpoints include quantifying injury associated with different baseball movement using the proposed system, development of algorithms to quantify workloads associated with injury during common baseball movements and validation of basic device measurements (Pilot Phase).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overuse Injury
Keywords
Healthy subjects, Athletes, Baseball, Sports research, overuse injuries

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a wearable prototype device for monitoring upper extremity sports related forces translated to the body during activity. The system will track exposure to injurious forces and monitor adherence to sport specific overuse standards and prescribed rehab regimens.
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Throwing Device Phase 1
Arm Type
Experimental
Arm Description
During Phase 1, subjects that have been recruited, consented, and enrolled will come to the biomechanics laboratory for throwing performance housed at the University of Pennsylvania (Human Motion Laboratory) on the day of their appointment. Subjects will be asked to wear the prototype device during a simulated baseball game (approximately 30-45 pitches), and then will perform a set of other baseball-specific movements while fitted with infrared markers for throwing analysis. This data will be used to develop and refine the algorithm for the prototype.
Intervention Type
Device
Intervention Name(s)
Throwing Device
Intervention Description
The Innovative Design Labs ( IDL) PhySens will be used to monitor the physical motions of subjects during standard sports-related actions (e.g. throwing a baseball). For this test, the PhySens Carrier will be attached via clothing rivets to a fabric sleeve or strap made of compliant materials commonly used in clothing and wearable products (e.g. nylon, spandex, neoprene).
Primary Outcome Measure Information:
Title
Feasibility of wearing the PhySens throwing device during simulated baseball play
Description
Subjects will be asked to put on the PhySens throwing monitor device prototype at the beginning of their physical therapy session and will wear the device for the duration of the visit or until asked by a member of the study team to remove the device.The device will collect motion data for the duration of the session.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of occurrences of injury associated with simulated baseball play
Description
Algorithms will be developed to quantify injury associated with common baseball injures from subjects wearing the prototype device and participate in a simulated game. Participants will pitch approximately 30-45 times using varying pitch types.
Time Frame
12 months
Title
Motion Capture Data Quantification common to baseball play
Description
Motion-capture data on movements common to baseball play will be captured from participants wearing the device. Participants will be fitted with 51 infrared reflective markers to enable tracking of limb, torso, and head movement while actions are performed. Movement data will be video recorded and recorded with 12 Motion Analysis Raptor IR cameras
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pilot Phase: Males or females age 8 to 14 years Presenting to the Children's Hospital of Philadelphia (CHOP) Physical Therapy Clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements. Phase 1: Males or females age 8 to 14 years Involved in official baseball team and primarily plays as the pitcher Exclusion Criteria: Pilot Phase Injury of any aspect of the throwing arm Unwillingness to perform all requested motions Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study procedures. Phase 1 Injury or disability impeding ability to perform normal baseball-related movements Inability/unwillingness to schedule and/or travel to the Human Motion Laboratory Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Greenberg, PT,DPT,PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Todd Lawrence, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Throwing Device Trial

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